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甘露醇注射液在室温20~30℃贮存相对稳定,若室温<15℃时则多析出结晶。鉴于在同等条件下,同时存在着有、无结晶拆出两种状态,经对析出结晶品进行澄明度复检,结果:合格率仅为53%。澄明度复检合格的亦不符合药典注射液不溶性微粒显微检查要求。经监测表明,在同等条件下,部分制品析出结晶,除温度因素外,尚与其澄明度相关。
Mannitol injection at room temperature 20 ~ 30 ℃ storage is relatively stable, if the room temperature <15 ℃, the more precipitation crystallization. In view of the same conditions, both at the same time, there is no crystallization of the two demolition of the state, after the crystallization of the crystal clear re-examination results: the passing rate of only 53%. Clarity re-examination of qualified does not meet the pharmacopoeia injection of insoluble particles microscopic examination requirements. Monitoring shows that under the same conditions, some products precipitation crystallization, in addition to temperature, but also with its clarity related.